SemperForce Blue Nitrile Exam Glove BKLF105

GUDID 00841277105896

SemperForce Blue Nitrile Exam Glove, size XL

SEMPERMED USA, INC.

Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device ID00841277105896
NIH Device Record Keyfbf62958-b127-4aaa-b545-571519361e8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSemperForce Blue Nitrile Exam Glove
Version Model NumberBKLF105
Catalog NumberBKLF105
Company DUNS004072158
Company NameSEMPERMED USA, INC.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100841277105858 [Primary]
GS100841277105896 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-20
Device Publish Date2020-07-10

On-Brand Devices [SemperForce Blue Nitrile Exam Glove]

00841277105926SemperForce Blue Nitrile Exam Glove, sample pack
00841277105896SemperForce Blue Nitrile Exam Glove, size XL
00841277105889SemperForce Blue Nitrile Exam Glove, size L
00841277105872SemperForce Blue Nitrile Exam Glove, size M
00841277105865SemperForce Blue Nitrile Exam Glove, size S

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.